Ethical Issues in Research-JSG NSG 456

ETHICAL ISSUES IN RESEARCH 2 Ethical Issues in Research With obesity on the rise in the United States, and the prevalence of outpatient arthroscopic rotator cuff repairs, the following question needs to be answered: “ ...

ETHICAL ISSUES IN RESEARCH 2 Ethical Issues in Research With obesity on the rise in the United States, and the prevalence of outpatient arthroscopic rotator cuff repairs, the following question needs to be answered: “how does obesity affect the surgical outcomes of outpatient arthroscopic rotator cuff repair patients versus nonobese patients?” In order to answer this question, a research study needs to be conducted. The research study must follow the seven main principles of research ethics and be independently reviewed for validity. Below is a review of how this study follows the seven main principles of research ethics. Research Ethics Guidance Ethics are rules and principles that guide decisions and conduct as they relate to right, wrong and what ought to be. Historically, some research studies were unethical; treating patients poorly, withholding treatment, and not informing patients of effects of medications and procedures. Because of this, codes of ethics in research have been established to help guide researchers and provide test subjects with informed consent. According to NIH (n.d.), “using these sources of guidance and others, seven main principles have been described as guiding the conduct of ethical research: social and clinical value; scientific validity, fair subject selection; favorable risk-benefit ratio; independent review; informed consent; respect for potential and enrolled subjects” (Patient Recruitment, para 3). These seven main principles are important for conducting ethical research studies. Social and Clinical Value Obese patients have multiple comorbidities. According to the CDC (n.d.), “people who are obese, compared to those with a normal or healthy weight, are at increased risk for many serious diseases and health conditions” (The Health Effects of Overweight and Obesity, para 1). These comorbidities put patients at a higher risk when having surgical procedures and the This study source was downloaded by 100000825931745 from CourseHero.com on 05-14-2021 20:47:02 GMT -05:00 https://www.coursehero.com/file/25974674/Ethical-Issues-in-Research-JSGdocx/ This study resource was shared via CourseHero.com ETHICAL ISSUES IN RESEARCH 3 healing/recovery process. By studying the difference in outcomes for obese arthroscopic rotator cuff repair patients and non-obese patients, perioperative nurses gain knowledge about their patients. Knowing these outcomes helps perioperative nurses to educate patients about the risks of being obese and having outpatient arthroscopic rotator cuff repair. By educating patients about the effects of obesity on their recovery after arthroscopic rotator cuff repair, patients have the ability to affect changes in their own lives to help them lose weight and improve their health, thus improving their surgical outcomes. Scientific Validity Obesity is proven to lead to major health issues such as hypertension, coronary artery disease, type two diabetes, cerebrovascular disease, and others. According to Namdari, Baldwin, Glaser, and Green (2010), “despite this, obesity as a risk factor for orthopaedic surgery is less commonly evaluated, and the findings have been variable” (p. 1250-1251). The question “how does obesity affect the surgical outcomes of outpatient arthroscopic rotator cuff repair patients versus non-obese patients?” needs to be assessed. Ambulatory surgery center A (ASC A) is where the surgeries are performed by three different orthopedic surgeons. The patients’ baseline data is collected and compared; this includes preoperative clinical data regarding existing comorbidities, past medical history, and past surgical histories, as well as a Disabilities of the Arm, Shoulder, and Hand (DASH) scorecard, a Simple Shoulder Test (SST) questionnaire. The patients’ recoveries/outcomes are followed for six months post-procedure using the DASH scorecard, a SST questionnaire, and review of postoperative physical assessments of the patients by their respective surgeons at the six weeks, three months, and six months postoperative visits. This study source was downloaded by 100000825931745 from CourseHero.com on 05-14-2021 20:47:02 GMT -05:00 https://www.coursehero.com/file/25974674/Ethical-Issues-in-Research-JSGdocx/ This study resource was shared via CourseHero.com ETHICAL ISSUES IN RESEARCH 4 Patients are placed into obese and non-obese (control group) categories based on definitions provided by the National Institutes for Health (NIH) and their baseline clinical data is compared. According to NIH (n.d.), “to diagnose overweight and obesity, doctors measure BMI using calculations that depend on whether you are a child or an adult. A healthy weight for adults is usually when your BMI is 18.5 to less than 25” (Overweight and Obesity, Diagnosis, para 2). Obesity is diagnosed with a BMI of 30 or greater. Fair Subject Selection and Informed Consent The subjects selected for the study are all patients having arthroscopic repair of a primary full-thickness rotator cuff tear. These patients are between the ages of 18 and 80, having outpatient surgery at ASC A between October 1, 2017 and March 31, 2018. The patients are assigned a study identification number, and are only identified by this number and their age so that none of their personal identification data is disclosed during the study. Patients are given all information regarding the study, and are volunteering for the study without coercion. According to NIH (n.d.), “this is done through a process of informed consent in which individuals (1) are accurately informed of the purpose, methods, risks, benefits, and alternatives to the research, (2) understand this information and how it relates to their own clinical situation or interests, and (3) make a voluntary decision about whether to participate” (Patient Recruitment, para 9). Favorable Risk-Benefits Ratio The risk-benefit ratio is favorable for the patients in this study as they are already scheduled to have arthroscopic rotator cuff repair surgery and follow-up. Patient will only need to complete a DASH scorecard and SST question